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MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

NCT05815329 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-08

No results posted yet for this study

Summary

Subjective cognitive decline-SCD is a subclinical cognitive impairment subjectively experienced without being detectable from a diagnostic and neuropsychological perspective. It can negatively impact on patient's frailty and quality of life and it may be prodromal to severe cognitive impairment. Currently, only a few screening tools focusing mainly on memory complaints exist.

The aim of this study is to analyze if a new screening tool called MASCoD (Multidimensional Assessment of Subjective Cognitive Decline) can detect and monitor the SCD, predicting the risk of developing severe cognitive decline over time.

Specifically, the investigators have the following aims:

primary objectives:

1. To assess the construct validity and tune the clinical cutoffs of the new instrument through the correlation of MASCoD scores with neuropsychological evaluation and brain 18F-FDG-PET.
2. To assess the clinical validity (predictive capability) of the new instrument through a classification model (dependent variable: brain 18F-FDG-PET examination; independent variable: MASCoD; control variables: gender, age and neuropsychological evaluation).

Secondary objective:

To evaluate the suitability of MASCoD as tool for the monitoring of patients over time. Specifically, the investigators want to evaluate if the MASCoD score is able to assess the effects of a cognitive treatment and, in turn, to identify outpatients who most likely will benefit from it.

After the multidimensional evaluation at T0, the participants will be randomly allocated into an experimental group and a wait list control group. Specifically, cognitive training will be offered by means of technological devices (Neurotablet).

At T1, all outpatients (experimental group and wait list control group) will be evaluated through MASCoD and the extensive neuropsychological evaluation for the second time.

Conditions

Interventions

OTHER

cognitive training

After the multidimensional evaluation at T0, the participants will be randomly allocated into an experimental group and a wait list control group. Specifically, cognitive training will be offered to half of the outpatients included in this research by means of technological devices (Neurotablet). A neuropsychologist will supervise the cognitive training offline (about 30 minutes per 5 days, 8 weeks) and through a face-to-face 1 hour-session each week per each outpatient.

Sponsors & Collaborators

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815329 on ClinicalTrials.gov